Medical Device Modifications Through Premarket Approval Supplements—Ensuring Patient Safety-Reference-Cited by-同舟云学术

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Medical Device Modifications Through Premarket Approval Supplements—Ensuring Patient Safety

Published:2023-04-12 Issue:4 Volume:6 Page:e237704
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Caughron Hope¹²,Dhruva Sanket S.²³⁴

Affiliation:

1. Division of Cardiology, University of California San Francisco School of Medicine, San Francisco

2. Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California

3. University of California San Francisco School of Medicine, San Francisco

4. Philip R. Lee Institute for Health Policy Studies, University of California San Francisco

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2803742/caughron_2023_ic_230046_1680705745.24031.pdf

Reference7 articles.

1. Risk of recall associated with modifications to high-risk medical devices approved through US Food and Drug Administration supplements.;Dubin;JAMA Netw Open,2023

2. Incremental revisions across the life span of ophthalmic devices after initial Food and Drug Administration premarket approval, 1979-2015.;Gopal;Ophthalmology,2017

3. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.;Rome;JAMA,2014

4. Characteristics of clinical studies used for US Food and Drug Administration approval of high-risk medical device supplements.;Zheng;JAMA,2017

5. How do orthopaedic devices change after their initial FDA premarket approval?;Samuel;Clin Orthop Relat Res,2016

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Use of patent term extensions to restore regulatory time for medical devices in the United States;Expert Review of Medical Devices;2024-06-02

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